Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
- Determine the complete response and partial response rates in patients with recurrent
or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
- Determine the overall and failure-free survival of patients treated with the
- Determine the duration of response (complete or partial) in patients treated with this
- Determine the percentage of patients who experience a 50% fall of serum
carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving
- Evaluate the toxicity associated with the administration of this regimen in these
OUTLINE: This is a non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Response Rate as Measured by RECIST Criteria
Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
4 - 6 months
Caio Max S. Rocha Lima, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|